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The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The secondary objective is to make a preliminary evaluation of the immunogenicity of each of the 3 doses of the vaccine in healthy volunteers.

Detailed Description

There is an urgent need for new tools to control human hookworm infection and to reduce its burden of disease in developing countries. This is especially true for children and women of reproductive age who represent populations that are highly vulnerable to the effects of hookworm disease. Up to 65,000 deaths annually have been attributed to human hookworm infection. However, the mortality estimates of hookworm pale in comparison to global disease burden estimates.

The primary approach to hookworm control worldwide has been the frequent and periodic use of benzimidazole anthelminthics for school-age children. However, school-based anthelminthic chemotherapy programs miss populations highly vulnerable to hookworm, including adolescent and adult women. In addition, high rates of hookworm re-infection occur within 4-12 months following anthelminthic chemotherapy, and there is evidence for diminished efficacy of benzimidazoles with frequent and periodic use, possibly because of emerging drug resistance. These concerns have prompted interest in developing alternative tools for hookworm control. Vaccination to prevent high intensity hookworm infection would alleviate the public health deficiencies of drug treatment alone.

All subjects must agree to use an acceptable method of birth control from the start of screening until 2 weeks after the third injection. Acceptable methods for female subjects include hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, condoms, abstinence, surgically sterile (hysterectomy), and surgically sterile partner. Acceptable methods for male subjects include surgical sterilization, condoms, partner who uses an acceptable method of birth control, and abstinence.

Exclusion Criteria:

Any history of anaphylaxis or allergy to vaccine components or allergy to insect stings, including bee stings.

A past or current history of hookworm infection.

BMI < 18.0 or > 30.0.

Recent (< 72 hours) history of febrile illness at the time of vaccination (temperature > 99.6°F or equivalent).

Received any immune globulin or blood product 3 months prior to injection or scheduled within 4 weeks thereafter.

Had vaccination with a live virus vaccine within 4 weeks before receipt of the vaccine or scheduled within 4 weeks thereafter.

Had vaccination with a killed vaccine, or allergy treatment with antigen injections within 14 days of initial study injection.

Received an investigational agent within 4 weeks of initial study injection.

Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment (creatinine > 1.5), any history of malignancy (except squamous cell or basal cell skin cancer), HIV infection or autoimmune diseases, or concomitant immunosuppressive medication such as glucocorticosteroids.